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BRIEF TITLE: Single Bladder Instillation of Mitomycin C vs. Gemcitabine vs. No Additional Treatment Immediately After TURBT of Bladder Tumor

A Prospective, Open-label Randomized Clinical Trial of a Single Bladder Instillation of Mitomycin C vs. Gemcitabine vs. No Additional Treatment Immediately After Transurethral Resection of Bladder Tumor (TURBT)


  • Org Study ID: Version 4 Date: 04.08.2016
  • Secondary ID:
  • NCT ID: NCT02695771
  • NCT Alias:
  • Sponsor: Spectrum Health Hospitals - Other
  • Source: Spectrum Health Hospitals

Brief Summary

To compare the efficacy of Mitomycin C vs. Gemcitabine vs. no adjuvant treatment as a single intraoperative instillation in preventing recurrence of bladder cancer.

Detailed Description


This study will compare standard of care treatment for patients with non-muscle invasive
bladder cancer (NMIBC). Patients will be randomized to one of three arms, Mitomycin C,
Gemcitabine or no additional treatment immediately following TURBT in the operating suite.
All treatment, surgical procedures and follow up care will be conducted according to standard
of care treatment.

Overal Status Start Date Phase Study Type
Recruiting Start Date: April 2016 Phase 3 Interventional

Primary Outcomes:

Primary Outcome 1 - Measure: Efficacy will be measured by the number of patients with Grade 3 through Grade 5 Adverse Events that are related to study treatment, graded according to NCI CTCAE Version 4.03

Primary Outcome 1 - Time Frame: Two years

Condition:

  • Urinary Bladder Neoplasms

Eligibility

Criteria:
Inclusion Criteria:

1. sign an informed consent for the study

2. be scheduled for a TURBT for suspected non-muscle invasive bladder tumor.

Exclusion Criteria:

1. patients unable to consent for themselves

2. individuals under 18 years old

3. pregnant women

4. prisoners

5. patients with known allergy or intolerance to the mitomycin C or Gemcitabine

6. any other sound medical, psychiatric and/or social reason as determined by the
investigator.
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Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

Official Information

Name: John E Humphrey, MD

Role: Principal Investigator

Affiliation: Spectrum Health Hospitals

Overall Contact

Name: Susan M Engerman, BSN

Phone: 616-267-8406

Email: susan.engerman@spectrumhealth.org

Locations

Facility Status Contact
Spectrum Health Medical Group-Division of Urology-LHCP
Grand Rapids, Michigan 49503
United States
Recruiting Susan M Engerman, BSN
616-267-8406
susan.engerman@spectrumhealth.org
Spectrum Health Medical Group-Division of Urology
Grand Rapids, Michigan 49503
United States
Recruiting Susan M Engerman, BSN
616-267-8406
susan.engerman@spectrumhealth.org
Urologic Consultants P.C.
Grand Rapids, Michigan 49503
United States
Recruiting Susan M Engerman, BSN
616-267-8406
susan.engerman@spectrumhealth.org